Skip to main content
. 2016 Dec 15;2016(12):CD009780. doi: 10.1002/14651858.CD009780.pub3

Hamann 2006.

Methods Allocation: cluster‐randomised trial.
Blindness: not blind.
Duration: 18 months.
Participants Diagnosis: schizophrenia or schizophreniform disorder.
N of clusters: 12 acute psychiatric wards.
N of participants: 107.
Sex: 59% M (experimental group); 47% M (control group).
Mean age, years: 35.5 (experimental group); 39.6 (control group).
Exclusion criteria: severe mental retardation, lack of fluency in German and refusal to give written informed consent.
Setting: two German state hospitals.
Interventions 1. Printed decision aid plus planning talk. A printed decision aid was initially developed in co‐operation with a number of psychiatrists, psychiatric nurses and former patients. The final version of the decision aid was a 16‐page booklet covering the pros and cons of oral versus depot formulations, first‐ versus second‐generation antipsychotics, psychoeducation and types of sociotherapeutic interventions. These booklets were presented to participants through the head nurse of the ward as soon as the psychiatrist in charge believed that participants were able to co‐operate. The nurses had been trained in assisting participants to work through the booklet and in answering any requests for information. Within the decision aid, participants were asked to write down their experiences with previous antipsychotic medications and to indicate their preferences on each topic regarding the available options. Participants met with their physicians within 24 hours after working through the decision aid with their nurse so they could reach an agreement with the psychiatrist on further treatment according to the preferences indicated by the participant in the booklet. Target of the intervention: nurses and doctors.
2. Routine care.
Outcomes Global state: PANSS.
Satisfaction with treatment: ZUF8.
Drug attitude: DAI.
Notes Mean number of participants per cluster (m): 8.9.
Intraclass coefficient (ICC): not reported.
Design effect: 1.79.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomization was done at the level of the wards to avoid intervention and control conditions being confounded".
Quote: "Selection of the wards was made so as to ensure that there were six pairs of wards, with one member of each pair being randomly assigned to the control or to the interventional condition".
Allocation concealment (selection bias) Unclear risk No details reported.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk No blinding.
Incomplete outcome data (attrition bias) 
 All outcomes High risk At follow‐up (18 months), data were available for 66% of the initial sample.
Selective reporting (reporting bias) Low risk All outcome measures reported in the Methods were included in the analysis and reported in the Results.
Other bias Unclear risk At baseline, the two groups were not perfectly balanced in terms of length of hospitalisation and psychopathology ratings. The trial was funded by the German Ministry of Health and Social Security (217‐43794‐5/9) within the funding project Der Patient als Partner im medizinischen Entscheidungsprozess.